FDA product code FNP: Urinal
FNP is the FDA product code for urinal. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FNP. The average 510(k) review took 13 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Urinal |
| Device class | Class I |
| Regulation | 21 CFR 880.6730 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FNP clearance
Top FNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bemis Health Care | 1 | 1977-09-28 |
Most recent FNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771738 | Bemis Health Care | MALE URINAL | 1977-09-28 | 13 |
Recalls for FNP devices
openFDA lists no recalls for product code FNP.
Frequently asked questions
What is FDA product code FNP?
FNP is the FDA product code for urinal. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.
What device class is FNP?
Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNP?
Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).
Which companies have the most FNP clearances?
Bemis Health Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FNP
- Run a recall and safety report across every FNP manufacturer
- Watch product code FNP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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